50 mg solution for injection in pre-filled pen 
etanercept

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • Your doctor will also provide you with a patient card that contains important safety information that you must be aware of before and during treatment with Benepali.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you or your child only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours or your child’s.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Benepali is and what it is used for 
2. What you need to know before using Benepali 
3. How to use Benepali 
4. Possible side effects 
5. How to store Benepali 
6. Contents of the packaging and other information 

1. What Benepali is and what it is used for

Benepali contains the active substance etanercept.

Benepali is a drug made from two human proteins. It binds to another protein that causes inflammation and blocks its activity. This blockage reduces the inflammation associated with the disease.

In adults (18 years and older) Benepali can be used for:

  • moderate or severe rheumatoid arthritis ;
  • psoriatic arthritis
  • severe axial spondylarthritis including ankylosing spondylitis ;
  • moderate or severe plaque psoriasis.

Benepali is most often used when other commonly used treatments have not worked well enough or are unsuitable for you.

Benepali is usually used in combination with methotrexate to treat rheumatoid arthritis, but it can also be used as the only medicine if treatment with methotrexate is unsuitable for you. Whether Benepali is used as a single drug or in combination with methotrexate, Benepali can slow down the damage to your joints caused by rheumatoid arthritis and improve your ability to perform daily activities.

For patients who have multiple joints affected by psoriatic arthritis, Benepali can increase the ability to perform daily activities.

For patients with multiple symmetrical aching or swollen joints (eg hands, ankles, and feet), Benepali may delay the breakdown of joint surfaces.

Benepali is also used to treat the following diseases in children and adolescents:

  • For the following types of childhood rheumatism ( juvenile idiopathic arthritis ), when treatment with methotrexate has not given sufficient results or is not appropriate:
    • Inflammation of many joints (polyarthritis) (rheumatoid factor positive or negative) and inflammation affecting 5 or more joints (enlarged oligoarthritis) in patients from 2 years of age and weighing 62.5 kg or more
    • Arthritis associated with the skin disease psoriasis (psoriatic arthritis) in patients from the age of 12 and weighing 62.5 kg or more
  • For patients from the age of 12 years and weighing 62.5 kg or more with musculoskeletal and tendinitis (enthesitis-related arthritis ) when other standard treatments have not given sufficient results or are not suitable
  • Severe plaque psoriasis in patients from 6 years of age weighing 62.5 kg or more who have had the insufficient effect of (or who cannot be treated with) light therapy or other systemic therapies (whole body medicines).

2. What you need to know before using Benepali

Do not use Benepali

  • if you or your child are allergic to etanercept or any of the other ingredients of this medicine (listed in section 6). If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Benepali and contact your doctor immediately.
  • if you or your child have or are at risk of developing a serious blood infection called sepsis. If you are not sure, talk to your doctor.
  • if you or your child have an infection of any kind. If you are not sure, talk to your doctor.

Warnings and cautions

Talk to your doctor before using Benepali.

  • Allergic reactions: If you or your child have allergic reactions, such as shortness of breath, wheezing, dizziness, or rash, stop injecting Benepali and contact your doctor immediately.
  • Infections/surgeries: If you or your child develop a new infection or are facing a major operation, your doctor may want to monitor your treatment with Benepali.
  • Infections / Diabetes: Tell your doctor if you or your child have had a recurring infection or have diabetes or any other condition that increases the risk of infection.
  • Infections/follow-up: Tell your doctor if you have recently been traveling outside of Europe. If you or your child develops symptoms of an infection such as fever, chills, or cough, consult a doctor immediately. Your doctor may want to continue to monitor you or your child for the presence of infection after you have stopped treatment with Benepali.
  • Tuberculosis: As cases of tuberculosis have been reported in patients treated with Benepali, your doctor will perform an examination to see if there are any signs of tuberculosis before starting treatment with Benepali. This may include a thorough review of your medical history, a chest x-ray, and a tuberculin test. The results of these examinations must be entered on the patient card. It is important that you tell your doctor if you or your child have ever had tuberculosis or had close contact with a person who has had tuberculosis. If symptoms of tuberculosis (eg persistent cough, weight loss, general deterioration, or mild fever) or any other infection occurs during treatment, contact your doctor immediately.
  • Hepatitis B: Tell your doctor if you or your child have or have ever had hepatitis. Your doctor should take a test for hepatitis B before you or your child start treatment with Benepali. Treatment with Benepali may result in the reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. If this happens, treatment with Benepali should be stopped.
  • Hepatitis C: Tell your doctor if you or your child have hepatitis C. Your doctor may want to check your treatment with Benepali if the infection worsens.
  • Blood disorders: Seek immediate medical attention if you or your child have symptoms such as persistent fever, sore throat, bruising, bleeding, or pallor. Such symptoms may indicate a potentially life-threatening blood disorder, which requires treatment with Benepali to be discontinued.
  • Nervous system and eye diseases: Tell your doctor if you or your child have multiple sclerosis, optic neuritis ( inflammation of the nerves in the eye), or transverse myelitis ( inflammation of the spinal cord). Your doctor will decide if Benepali is the right treatment.
  • Heart failure: Tell your doctor if you or your child have a history of heart failure, as Benepali must be used with caution in such circumstances.
  • Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other type of cancer before you get Benepali. Patients with severe rheumatoid arthritis who have had the disease for a long time may have a higher-than-average risk of developing lymphoma. Children and adults who use Benepali may be at greater risk of developing lymphoma other types of cancer. Some children and teens who have been given Benepali or other drugs that work similarly to Benepali have developed cancer, including unusual types that sometimes led to death. Some patients who have received Benepali have developed skin cancer. Tell your doctor if you or your child develops any type of skin change or growth on the skin.
  • Chickenpox: Tell your doctor if you or your child have been exposed to chickenpox during treatment with Benepali. Your doctor will decide if you need to be prescribed preventative treatment for chickenpox.
  • Alcohol abuse: Benepali should not be used to treat hepatitis related to alcohol abuse. Tell your doctor if you or your child have a history of alcohol abuse.
  • Wegener’s granulomatosis: Benepali is not recommended for the treatment of Wegener’s granulomatosis, a rare inflammatory disease. Talk to your doctor if you or your child have Wegener’s granulomatosis.
  • Medicines for diabetes: Tell your doctor if you or your child have diabetes or are taking medicines to treat diabetes. Your doctor will decide if you or your child needs a smaller dose of the drug for diabetes during treatment with Benepali.
  • Vaccinations: Some vaccines, e.g. oral polio vaccine, should not be given during treatment with Benepali. Contact a doctor before you or your child receive any vaccines.

Children and young people

Benepali is not intended for children and adolescents weighing less than 62.5 kg.

  • Vaccinations: If possible, children should have received all vaccinations according to the vaccination program before starting treatment with Benepali. Some vaccines, such as the oral polio vaccine, should not be taken at the same time as Benepali treatment. Check with your or your child’s doctor before you or your child receive any vaccination.
  • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with etanercept. Tell your child’s doctor if your child has abdominal pain or abdominal cramps, diarrhea, weight loss, or blood in the stool.

Benepali should not normally be used in children under 2 years of age or weighing less than 62.5 kg with polyarthritis or extended oligoarthritis, or in children under 12 years of age or weighing less than 62.5 kg with enthesitis-related arthritis or psoriatic arthritis, or for children under 6 years of age or weighing less than 62.5 kg with psoriasis.

Other medicines and Benepali

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines (including sulfasalazine).

You or your child should not use  Benepali with other medicines that contain the active substances anakinra or abatacept.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during treatment with Benepali and for three weeks after stopping treatment.

Benepali should only be used during pregnancy if absolutely necessary.

If you have had Benepali during pregnancy, your baby may be at greater risk of getting an infection. One study also found more malformations when the mother had received etanercept during pregnancy, compared with mothers who had not received etanercept or other similar drugs ( TNF – antagonistic), but no specific type of malformation was reported. Another study did not show an increased risk of malformations when the mother received etanercept during pregnancy. Your doctor will help you determine if the benefits of the treatment outweigh the potential risk to your child. It is important that you tell your baby’s doctor or another healthcare professional if Benepali has been used during pregnancy before vaccinating your baby (for more information, see section 2, “Vaccinations”).

You should not breast-feed while using Benepali as Benepali passes into breast milk.

Driving and using machines

There is no information that the use of Benepali affects the ability to drive or use machines.

Benepali contains sodium

Benepali contains less than 1 mmol sodium (23 mg), ie essentially ‘sodium-free’.

3. How to use Benepali

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

If you have the impression that the effect of Benepali is too strong or too weak, talk to your doctor or pharmacist.

Use in adult patients (over 18 years of age)

Rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis including ankylosing spondylitis

The recommended dose is 50 mg once a week in the form of an injection under the skin.

Your doctor may decide on a different frequency for injecting Benepali.

Plaque psoriasis

The recommended dose is 50 mg given once a week.

Alternatively, 50 mg can be given twice a week for up to 12 weeks followed by 50 mg once a week.

Your doctor will decide how long you should use Benepali and if resuming treatment is needed based on the treatment results. If Benepali has not had any effect on your condition after 12 weeks, your doctor may ask you to stop treatment.

Use for children and adolescents

Dose one and how often it should be given to the child or adolescent depends on body weight and illness. The doctor determines the correct dose for the child and prescribes etanercept with appropriate strength. Pediatric patients weighing 62.5 kg or more may be given 25 mg twice a week or 50 mg once a week with a pre-filled syringe or pre-filled pen at a set dose.

There are other medicines with etanercept in suitable dosage form available for children.

For patients from 2 years of age and weighing 62.5 kg or more with polyarthritis or extended oligoarthritis, or for patients from 12 years of age and weighing 62.5 kg or more with encephalitis-related arthritis or psoriatic arthritis, the usual dose is 25 mg twice a week or 50 mg once a week.

For patients from 6 years of age who weigh 62.5 kg or more with psoriasis, the usual dose is 50 mg given once a week. If Benepali does not show any effect after 12 weeks, your doctor may ask you to stop treatment with this medicine.

Your doctor will provide you with detailed instructions for the preparation and measurement of the correct dose.

Method and route of delivery

Benepali is injected under the skin ( subcutaneous use).

Detailed instructions on how to inject Benepali can be found in section 7 “Instructions for use”. Do not mix the Benepali solution with any other medicine.

To make it easier for you to remember, it can be helpful to write in a calendar which days of the week Benepali should be taken.

If you have used too much Benepali

If you have injected more Benepali than your doctor has prescribed (either by injecting too much at one time or taking one dose too much) you should contact either your doctor or pharmacist immediately. Always carry the labeled outer packaging of the medicine, even if it is empty.

If you forget to use Benepali

If you miss a dose, you should inject one as soon as you remember, unless the next scheduled dose is to be taken the next day, then skip the missed dose. Then continue to inject the medicine on the usual scheduled day. If you do not remember a dose until the day of the usual injection, do not take a double dose (two doses on the same day) to make up for a forgotten dose.

If you stop using Benepali

Your symptoms may return if treatment is stopped.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following symptoms occur, do not inject Benepali anymore, but contact your doctor immediately or the emergency department at the nearest hospital.

  • Difficulty swallowing or breathing.
  • Swelling of the face, neck, hands, or feet.
  • Feeling of nervousness or anxiety, throbbing sensation, sudden redness of the skin with or without feeling hot.
  • Severe skin rash, itching, or hives (red spots or pale skin that often itches).

Severe allergic reactions are rare, but one or more of the above symptoms may indicate an allergic reaction caused by Benepali and medical attention should be sought immediately.

Serious side effects are

If you or your child observes any of the following symptoms, seek medical attention immediately.

  • Symptoms of a serious infection (including pneumonia, deep skin infections, joint infections, and sepsis), such as high fever which may be associated with coughing, difficulty breathing, chills, feeling weak, or a hot, red, and tense surface in the skin or at a joint.
  • Symptoms of any blodsj u KDOM , such as bleeding, bruising, or pallor.
  • Symptoms of any neurological disease, such as loss of sensation and a stinging sensation, changes in vision, eye pain, or muscle weakness in the arms or legs.
  • Symptoms of heart failure or worsening heart failure, such as fatigue or difficulty breathing during exertion, swollen ankles, a feeling of swollen neck and abdomen, difficulty breathing at night, coughing, or bluish color on nails or lips.
  • Symptoms of cancer: Cancer can affect all parts of the body, including the skin and blood, and the symptoms depend on the type of cancer and its location. These symptoms may include weight loss, fever, swelling (with or without pain), persistent cough, lumps, or growths on the skin.
  • Symptoms of autoimmune reactions (when antibodies are formed that can damage the body’s normal tissues ) such as pain, itching, weakness, abnormal breathing, thoughts, sensations, or vision.
  • Symptoms of inflammatory bowel disease (lupus) or lupus-like syndromes such as weight change, persistent rash, fever, joint or muscle aches, or fatigue.
  • Symptoms of inflammation of the blood vessels such as pain, fever, redness, or feeling of warmth in the skin or itching.

These are rare or uncommon side effects, but serious (some of them can be fatal). If any of the above occur, contact your doctor or emergency department immediately at the nearest hospital.

Other side effects ar

Known side effects of Benepali are as follows, divided into groups according to decreasing frequency:

  • Very common (may affect more than 1 user in 10)Infections (including colds, sinusitis, bronchitis, urinary tract infections, skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, swelling).Injection site reactions (these often subside after the first month of treatment). Some patients develop a reaction at an injection site that has been used before.
  • Common (may affect up to 1 in 10 people)Allergic reactions; fever; rash; itching; antibodies are directed against normal tissue (autoantibody formation).
  • Uncommon (may affect up to 1 in 100 people)Serious infections, including pneumonia, deep skin infections, joint infections, sepsis and infection in various places, aggravated chronic heart failure, low red blood cell count, low white blood cell count, low neutrophil count (a type of white blood cell count ), low platelet count; skin cancer (excluding melanoma ); local swelling of the skin ( angioedema ); hives (red spots or pale skin that often itches); eye inflammation; psoriasis (new onset or worsening); inflammation the blood vessels that can affect several organs; elevated liver values ​​in blood tests (in patients also receiving methotrexate, the frequency of elevated liver values ​​is “normal”); cramps and pain in the abdomen, diarrhea, weight loss or blood in the stool (signs of intestinal disease).
  • Rare (may affect up to 1 in 1,000 people)Severe allergic reactions (including severe local swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukemia (cancer that affects the blood and bone marrow ); melanoma (a type of skin cancer); a combination of low platelet counts , red and white blood cells; effects on the nervous system (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves or spinal cord of the eye); tuberculosis; newly debuted heart failure; seizures; lupus or lupus-like symptoms (symptoms include persistent rash, fever, joint pain and fatigue); skin rash that can lead to severe blistering and flaking of the skin; inflammationin the liver caused by the body’s own immune system ( autoimmune hepatitis; in patients who also receive methotrexate, the frequency is “less common”); immune disease that can affect the lungs, skin and lymph nodes ( sarcoidosis ); inflammation or fibrosis of the lungs (in people who also receive methotrexate, the frequency of inflammationand fibrosis of the lungs is “less common”); lichenoid reactions (itchy red-purple rash and / or thread-like white-gray lines on mucous membranes); opportunistic infection (which includes tuberculosis and other infections)you arising from a weakened immune system); erythema multiforme (inflammatory skin rash); cutaneous vasculitis ( inflammation of the blood vessels in the skin); damage to nerves, including Guillain-Barré syndrome (a serious condition that can affect breathing and damage to body organs).
  • Very rare (may affect up to 1 in 10,000 people)Inability of bone marrow to produce blood cells; toxic epidermal necrolysis (a life-threatening skin disease).
  • No known frequency (cannot be calculated from the available data)Merkel cell cancer (a type of skin cancer); Kaposi’s Sarcoma (rare cancer associated with infection by human herpes virus 8. Kaposi’s sarcoma usually occurs as purple spots on the skin); overactivation of white blood cells associated with inflammation (macrophage activation syndrome); reactivation of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness accompanied by a rash); listeria (a bacterial infection ).

Side effects in children and adolescents

The side effects and their frequencies in children and adolescents are the same as in adults, see the description above.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Benepali

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label on the pre-filled pen after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C ‑ 8 ° C). Do not freeze.

Store the pre-filled pens in the outer carton. Sensitive to light.

After removing Benepali from the refrigerator, wait approximately 30 minutes for the Benepali solution in the pen to reach room temperature.

Do not heat Benepali in any other way. Thereafter, immediate use is recommended.

Benepali can be stored outside the refrigerator at temperatures up to a maximum of 25 ° C for a single period of up to four weeks, after which it should not be stored in the refrigerator again. Benepali should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date Benepali is removed from the refrigerator and the date Benepali is to be discarded (no longer than 4 weeks after removal from the refrigerator).

Inspect the solution in the pen by looking through the transparent inspection window. It should be clear or slightly opalescent, colorless or pale yellow, and may contain small white or almost transparent particles of protein. This appearance is normal for Benepali. Do not use this medicine if you notice that the solution is discolored, cloudy, or if particles other than those described above occur. If you have any further questions on the use of this solution, ask your pharmacist for help.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is etanercept. Each pre-filled pen contains 50 mg etanercept.
  • The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, and water for injections (see section 2 “Benepali contains sodium”).

What the medicine looks like and the contents of the pack

Benepali is supplied in a pre-filled pen. The pen contains a clear to slightly opalescent, colorless, or pale yellow solution for injection ( injection ).

Benepali is available in packs containing 4 pre-filled pens and in multipacks containing 3 cartons, each containing 4 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Samsung Bioepis NL BV

Olof Palmestraat 10

2616 LR Delft

The Netherlands

Manufacturer

Biogen (Denmark) Manufacturing ApS

Biogen Allé 1

3400 Hillerød

Denmark

Samsung Bioepis NL BV

Olof Palmestraat 10

2616 LR Delft

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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